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PT. QUALTEK CONSULTANT JAKARTA

Authorized Representative in Indonesia

Icon Business Park Blok K No 6, BSD City, Kab Tangerang, Banten
151 Products Represented
60 Manufacturers
Total Products
151
Manufacturers
60
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
8 products
5.3%
Kelas Resiko : B
29 products
19.2%
Kelas Resiko : C
96 products
63.6%
Kelas Resiko : D
18 products
11.9%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (151)
Complete portfolio registered with BPOM

MIACARE DELiGHT 1-Day Silicone Hydrogel Soft Contact Lens

Manufacturer:

VISCO TECHNOLOGY SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

CUSA Clarity Ultrasonic Surgical Aspirator System

Manufacturer:

INTEGRA LIFESCIENCES (IRELAND) LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2025

SAYPHA Volume Plus Lidocaine

Manufacturer:

CROMA-PHARMA GMBH (CROMAZEILE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 2, 2025

SAYPHA Filler Lidocaine

Manufacturer:

CROMA-PHARMA GMBH (CROMAZEILE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 2, 2025

SAYPHA Rich

Manufacturer:

CROMA-PHARMA GMBH (CROMAZEILE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2024

SAYPHA Volume Lidocaine

Manufacturer:

CROMA-PHARMA GMBH (CROMAZEILE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2024

SAYPHA FILLER

Manufacturer:

CROMA-PHARMA GMBH (CROMAZEILE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2024

SAYPHA Volume

Manufacturer:

CROMA-PHARMA GMBH (CROMAZEILE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2024

Goddess 1 Day Color Contact Lens

Manufacturer:

YUNG SHENG OPTICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 24, 2024

AIRFIT F40

Manufacturer:

RESMED ASIA PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2024

ACER MEDICAL Non-Mydriatic Automated Portable Fundus Camera

Manufacturer:

CRYSTALVUE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

CALCIPEX II

Manufacturer:

NIPPON SHIKA YAKUHIN CO., LTD., FUKUURA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

GODESS Monthly Color Contact Lens

Manufacturer:

YUNG SHENG OPTICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

PCI Guide Wire MINAMO

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

PEGAVISION Silicone Hydrogel Monthly Disposable Soft Contact Lenses

Manufacturer:

PEGAVISION CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

NEOSPROUT Nasal Hemostasis Sponge

Manufacturer:

NEO MODULUS (SHANDONG) MEDICAL SCI-TECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 17, 2024

PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses

Manufacturer:

PEGAVISION CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2024

NuCraft Tissue Adhesive

Manufacturer:

NEO MODULUS (SHANDONG) MEDICAL SCI-TECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

ACER MEDICAL VeriOsteo OP

Manufacturer:

ACER MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

DERMAANGEL Acne Patch

Manufacturer:

BENQ MATERIALS CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2024

DERMAANGEL Acne Patch Plus

Manufacturer:

BENQ MATERIALS CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2024

MIACARE CONFiDENCE Color Contact Lens with EautraSil Plus

Manufacturer:

BENQ MATERIALS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

RIGHTEST Lancing Device GD500

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 25, 2024

DYNAMIC ABUTMENT SOLUTIONS Multi-Unit System

Manufacturer:

TALLADIUM ESPANA, S.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2024

DYNAMIC ABUTMENT SOLUTIONS Accessories for prosthetic restoration

Manufacturer:

TALLADIUM ESPANA, S.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 12, 2024

AIRFIT P30i

Manufacturer:

RESMED ASIA PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 12, 2024

VOLUME INSTRUMENTS

Manufacturer:

MEDYTOX INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 12, 2024

ATIERE Classic

Manufacturer:

MEDYTOX INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 12, 2024

ATIERE Intensive

Manufacturer:

MEDYTOX INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 12, 2024

CLINY Pull PEG Kit

Manufacturer:

DALIAN CREATE MEDICAL PRODUCTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

AIRFIT F20 Full Face Mask System

Manufacturer:

RESMED ASIA PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 17, 2024

GVS Disposable heat and humidity exchange filter - BVF

Manufacturer:

GVS TECHNOLOGY (SUZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

LUMIS 150 VPAP ST-A

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2024

GVS Disposable heat and humidity exchange filter - HMEF

Manufacturer:

GVS TECHNOLOGY (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

AirFit N20 Nasal Mask System

Manufacturer:

RESMED ASIA PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 21, 2024

AIRSENSE 10 Autoset for Her

Manufacturer:

RESMED PTY., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

AIRCURVE 10 VAUTO

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2024

'Garmin" ECG App

Manufacturer:

GARMIN CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2024

LUMIS 150 VPAP ST

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 27, 2024

ASAHI Caravel Microcatheter

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 18, 2024

AirFit N20 Classic Mask System

Manufacturer:

RESMED ASIA PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 18, 2024

RESMED APNEALINK AIR

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2024

PERFIT Elastomeric Impression Material

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

ASTRAL 100

Manufacturer:

RESMED PTY., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2023

BIONIME RIGHTEST™ GC700 Control Solution

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

ASTRAL 150

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

STELLAR 150

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

ASAHI MEISTER 16 Peripheral Vascular Guide Wire

Manufacturer:

ASAHI INTECC HANOI CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

AIRFIT N20 Nasal Mask System

Manufacturer:

RESMED ASIA PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

AIRSTART 10 APAP

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

AIRFIT N20 Classic Mask System

Manufacturer:

RESMED ASIA PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

AIRSENSE 10 Elite

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

AIRSENSE 10 Autoset

Manufacturer:

RESMED PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

ASAHI Extension Wire

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

RIGHTEST™ Blood Glucose Monitoring System GM700

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

ASAHI Corsair Pro Microcatheter

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

ACUCARE F1-4 Full Face Mask

Manufacturer:

RESMED PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2023

RIGHTEST Blood Glucose Test Strip GS700

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2023

RIGHTEST GM700SB Blood Glucose Monitoring System

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2023

DEYES Color Biweekly Disposable Silicone Hydrogel Contact Lens

Manufacturer:

HOPE VISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2023

KEEOGO ™ Powered walking assistance devices

Manufacturer:

B-TEMIA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

AIRMINI

Manufacturer:

RESMED PTY.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

AirFit P10 Mask System

Manufacturer:

RESMED ASIA PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

AirFit P10 Mask System

Manufacturer:

RESMED PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

PEGAVISION Color Daily Disposable Soft Contact Lenses

Manufacturer:

PEGAVISION CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

PEGAVISION Daily Disposable Soft Contact Lenses

Manufacturer:

PEGAVISION CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

PEGAVISION Color Monthly Disposable Soft Contact Lenses

Manufacturer:

PEGAVISION CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

PEGAVISION Monthly Disposable Soft Contact Lenses

Manufacturer:

PEGAVISION CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

VINCISMILE Ceramic Coupling Agent

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

DEYES Color Daily Disposable Silicone Hydrogel Contact Lens

Manufacturer:

HOPE VISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

WHITEESSENCE Whitening Pro

Manufacturer:

WHITEESSENCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2023

ZIRKING Zirconia Block

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2023

Lunit INSIGHT MMG

Manufacturer:

LUNIT INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2023

Lunit INSIGHT CXR

Manufacturer:

LUNIT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2023

Jalupro Super Hydro

Manufacturer:

AGRI-BIO-ECO LABORATORI RIUNITI S.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 12, 2023

VinciSmile Enamel Coating Resin

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2023

ASAHI Silverway Hydrophilic Coated Spring Coil Guide Wire

Manufacturer:

ASAHI INTECC HANOI CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2023

VINCISMILE Light Cure Dental Adhesive

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

VINCISMILE Phosphoric Acid Etching Gel

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ASAHI PTCA Guide Wire Miracle

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2023

ASAHI FUBUKI Neurovascular Guide Catheter

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2023

ASAHI VELOUTE Microcatheter

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2023

ASAHI PTCA Guide Wire ASAHI SUOH 03

Manufacturer:

ASAHI INTECC HANOI CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

ASAHI Neurovascular Guide Wire

Manufacturer:

ASAHI INTECC HANOI CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

ASAHI PTCA Guide Wire ASAHI SION blue ES

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

ASAHI PTCA Guide Wire ASAHI SION

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

ASAHI PTCA Guide Wire ASAHI SION blue

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

ASAHI TELLUS Microcatheter

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

ASAHI Tornus Support Catheter

Manufacturer:

ASAHI INTECC (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

ASAHI CHIKAI V Peripheral Vascular Guide Wire

Manufacturer:

ASAHI INTECC HANOI CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

PULSECATH iVAC 2L

Manufacturer:

PULSECATH B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 8, 2023

CLARITAS iRAD

Manufacturer:

CLARITAS HEALTHTECH PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ACER MEDICAL VeriSee DR

Manufacturer:

ACER MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

ACER MEDICAL VeriSee DR

Manufacturer:

ACER MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

MIACARE CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

Manufacturer:

BENQ MATERIALS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 31, 2022

BRIGHTEN OPTIX Ortho-K Overnight Orthokeratology Contact Lens

Manufacturer:

BRIGHTEN OPTIX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2022

MIACARE CONFiDENCE Color Contact Lens with EautraSil Plus

Manufacturer:

BENQ MATERIALS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2022

CLINY All Silicone Nephrostomy Balloon Catheter

Manufacturer:

VIETNAM CREATE MEDIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2022

MIACARE DELiGHT 1-Day Contact Lens with EautraSil Plus

Manufacturer:

BENQ MATERIALS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

CLINY Balloon Button Set

Manufacturer:

VIETNAM CREATE MEDIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

MIACARE DELiGHT Contact Lens with EautraSil Plus

Manufacturer:

BENQ MATERIALS CORPORATION TAOYUAN FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2022

VINCISMILE Glass Ionomer Cement

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

VINCISMILE Glass Ionomer Cement

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2022

COMCAN PURITI Plus Daily Disposable Silicone Hydrogel Contact Lens

Manufacturer:

HOPE VISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2022

Us2.v1

Manufacturer:

EKO. AI PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2022

COMCAN PURITI Plus Monthly Disposable Silicone Hydrogel Contact Lens

Manufacturer:

HOPE VISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2022

PRUDENT Flat Panel Digital X-ray Detector

Manufacturer:

PIXXGEN CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2022

CLINY Ureteral Stent Set

Manufacturer:

DALIAN CREATE MEDICAL PRODUCTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2022

CLINY Nephrostomy Kit for PCNL

Manufacturer:

DALIAN CREATE MEDICAL PRODUCTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2022

AIRSENSE 10 Autoset FH APAC TRI C

Manufacturer:

RESMED, PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2022

AIRSENSE 10 AutoSet APAC TRI C

Manufacturer:

RESMED PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2022

SAVIEW-COLORS 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens

Manufacturer:

ST. SHINE OPTICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2022

AIRSENSE 10 Elite APAC TRI C

Manufacturer:

RESMED PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 28, 2022

ARTIBEST Intra-articular Injection

Manufacturer:

MAXIGEN BIOTECH INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 27, 2022

PRIMADO2 Total Surgical System and Accessories 2

Manufacturer:

NAKANISHI INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2022

PRIMADO2 Total Surgical System

Manufacturer:

NAKANISHI INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2022

HUGE Denture Base Polymers

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2022

HUGE Synthetic Polymer Teeth

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2022

N30 AirMini Mask Pack

Manufacturer:

RESMED PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2021

AIRFIT N30

Manufacturer:

RESMED ASIA PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2021

TRON FX II Thrombectomy Device

Manufacturer:

YOKOWO CO., LTD. TOMIOKA PLANT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2021

SAYPHA RICH

Manufacturer:

CROMA-PHARMA GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 31, 2021

SAYPHA FILLER

Manufacturer:

CROMA-PHARMA GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 31, 2021

SAYPHA VOLUME

Manufacturer:

CROMA-PHARMA GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 30, 2021

SAYPHA VOLUME PLUS LIDOCAINE

Manufacturer:

CROMA-PHARMA GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

ACER HEALTHCARE VeriSee DR

Manufacturer:

ACER HEALTHCARE INCORPORATED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2021

RIGHTEST Twist Lancet

Manufacturer:

STERILANCE MEDICAL (SUZHOU) INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 15, 2021

RIGHTEST Activated Safety Lancet

Manufacturer:

STERILANCE MEDICAL (SUZHOU) INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 15, 2021

AIRFIT N30i Quiet

Manufacturer:

RESMED ASIA PTE. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2021

Lunit INSIGHT CXR

Manufacturer:

LUNIT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2021

AIRFIT N30i Quiet

Manufacturer:

RESMED PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2021

FLOTON ST30

Manufacturer:

CURATIVE MEDICAL TECHNOLOGY INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2021

RIGHTEST Blood Glucose Monitoring System GM260

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

Invisible Orthodontic Appliance

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 1, 2021

RIGHTEST Blood Glucose Monitoring System ELSA

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2020

FLEXO ST30

Manufacturer:

CURATIVE MEDICAL TECHNOLOGY INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2020

RIGHTEST Blood Glucose Test Strip ELSA

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

GA ST40P Fan

Manufacturer:

CURATIVE MEDICAL TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

RIGHTEST Blood Glucose Test Strip GS260

Manufacturer:

BIONIME CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

MIACARE DELiGHT Monthly Silicone Hydrogel Soft Contact Lens

Manufacturer:

VISCO TECHNOLOGY SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2020

SAYPHA VOLUME Lidocaine

Manufacturer:

CROMA-PHARMA GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 4, 2020

SAYPHA FILLER Lidocaine

Manufacturer:

CROMA-PHARMA GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 4, 2020

RESMED AcuCare HFNC (High Flow Nasal Cannula)

Manufacturer:

RESMED PTY. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 26, 2020

LUNIT INSIGHT MMG

Manufacturer:

LUNIT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2020

ACUCARE F1-1 NV Full Face Mask with AAV

Manufacturer:

RESMED LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 2, 2020

ACUCARE F1-0 NV Full Face Mask

Manufacturer:

RESMED LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 14, 2020

PIXX Flat Panel Digital X-ray Detector

Manufacturer:

PIXXGEN CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2019

AIRFIT P30i

Manufacturer:

RESMED ASIA PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2019

AIRFIT P30i

Manufacturer:

RESMED LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2019

AIRFIT N30i

Manufacturer:

RESMED ASIA PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2019

AIRFIT P10 Mask System

Manufacturer:

RESMED ASIA PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025